- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00605982
Breast MRI as a Preoperative Tool for DCIS
Breast MRI is a fairly new technology, but it has been well studied. It is now used routinely in many patients with breast cancer. It has been shown to be useful in detecting areas of cancer that cannot be seen using other types of scans or tests.
The purpose of this study is to see how often MRI can find other areas of cancer in women with one area of breast cancer, and to determine how having the MRI test affects their treatment. The purpose is also to study any areas of abnormality seen on your MRI with special methods that allow the images of your breast tissue and the microscopic analysis of your breast tissue to be compared very carefully. The study also aims to follow women who enter the study over a 10-year period to determine how often the breast cancer comes back.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Cancer Center
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age less than 60 at time of consent
- Clinical stage is consistent with Stage 0 or Stage I T1mic at presentation
- Core biopsy proven DCIS or DCIS with microinvasion (invasion ≤0.1 cm), prior to enrollment
- Breast surgery to be performed at MSKCC
- Informed consent obtained
- Female
Exclusion Criteria:
- Age 60 or over at time of consent
- Patients who are pregnant or nursing
- Patients with contraindications to breast conservation
- Excisional biopsy of DCIS or DCIS with microinvasion, prior to enrollment
- Patients with any contraindications to MRI including pacemaker, tissue expander, other metallic surgical implants, weight over 350 lb., previous gadolinium reaction, metal fragments in eye
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Women with core biopsy proven DCIS with or without microinvasion seen for surgical consultation at Memorial Sloan-Kettering Cancer Center and for whom operative intervention is planned.
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The patient will then undergo a breast MRI as part of their preoperative work-up of DCIS.
Biopsy of any suspicious areas by needle biopsy or at the time of surgery.
If appropriate, repeat MRI after biopsy or surgery.
Follow-up for 10 years (you will be contacted once a year to see how you are doing).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS.
Time Frame: conclusion of the study
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conclusion of the study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the proportion of all patients in this study in whom breast MRI identifies at least one site of cancer separate from the index lesion.
Time Frame: conclusion of the study
|
conclusion of the study
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To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI.
Time Frame: conclusion of the study
|
conclusion of the study
|
To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning.
Time Frame: conclusion of the study
|
conclusion of the study
|
To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI.
Time Frame: conclusion of the study
|
conclusion of the study
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-124
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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